Remote COA Manager: Patient Outcomes & Trials

Alphanumeric Systems Inc

Durham (NC)

Hybrid

USD 69,000 - 74,000

Full time

14 days+

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Job summary

ViiV Healthcare seeks a Clinical Outcome Assessments (COA) Manager to support the Global Health Outcomes team in Durham, NC, with remote or onsite options. You will develop, validate, and implement COA instruments and patient-centered endpoints used in clinical trials and observational studies, emphasizing PRO, psychometrics, and measurement science.

Requirements include 3+ years in pharma/biotech, a related bachelor’s degree, and familiarity with FDA PFDD guidance; strong statistical and

Qualifications

Bachelor's degree in psychometrics, health outcomes research, epidemiology, biostatistics, public health, behavioral science, biomedical engineering, data science, or a related discipline.
3+ years of relevant experience within pharmaceutical, biotechnology, digital health, CRO, or academic environments.
Demonstrated experience with Clinical Outcome Assessments, patient-centered outcomes, or related measurement science.
Experience contributing to the development, validation, or implementation of COA instruments or digital measures in clinical trials.
Familiarity with statistical approaches used for COA/digital endpoints, including psychometric analysis, mixed-effects models, and responder analyses.
Working knowledge of FDA PFDD guidance and relevant international regulatory frameworks.

Responsibilities

Supporting the design and execution of COA development and validation studies, including patient-experience data collection and analysis.
Selecting, adapting, developing, validating, and implementing COA instruments for clinical trials and observational research.
Applying qualitative research methods, psychometric principles, and statistical approaches to evaluate measurement properties.
Supporting FDA and other health authority interactions related to COA and patient-centered endpoint strategies.
Contributing to briefing documents, regulatory submissions, endpoint rationale, protocols, SAP language, and responses to health authority questions.
Partnering cross-functionally with Biostatistics, Regulatory Affairs, Medical Affairs, Clinical Development, R&D, and Clinical Operations.
Supporting publications, conference presentations, and other external scientific activities.
Helping advance measurement-science standards and COA best practices across the portfolio.